FDA-FERN MICROBIOLOGICAL COOPERATIVE AGREEMENT CONTINUATION PROGRAM (U18) GRANT PROPOSAL Project Summary This grant proposal from the Ohio Department of Agriculture (ODA) is in response to a Funding Opportunity Announcement (FOA) from the Food and Drug Administration (FDA) Food Emergency Response Network (FERN). The goal of this proposal is to enhance the surge capacity and the capability of the FERN for the detection of microbiological pathogens in response to a food borne disease outbreak or a large scale food emergency event. The purpose of this application from ODA's Consumer Protection Laboratory's (CPL) Food Microbiology laboratory is to complement, develop, improve and utilize the capacity and capability of the laboratory in response to an event during which laboratory surge capacity is needed. Support will be provided to FERN and the FDA for analyses related to microbiological contamination, resulting from either intentional or unintentional introduction with availability of a 24 hour - 7 days a week response. This proposal addresses the three key project areas that FDA has identified as the critical functions integral to this project. As part of the proposal, a detailed view of the laboratory facilities is provided and supplemented with details of the laboratory support services and the campus security plan. To implement the projects outlined in the proposal, the qualifications and the work experience of CPL's staff is also presented. Additionally, the laboratory management practices are also explained in great detail. This grant proposal also addresses the FDA request for sample analysis commitment as well as the laboratory's ability and willingness to enter data into eLEXNET and notify FERN of analytical results in a timely manner. Several additional documents such as the Proficiency Testing Schedule (PT) have been provided along with the

Public Health Relevance

that showcase the laboratory's ability to provide the capacity and capability for conducting the surveillance testing as well as large scale outbreak testing for FERN. The Project narrative is attached under Line Item #3 (Research Strategy) in the PHS 398 Research Plan Component